Use, Effects and Side-effects of Second-generation Antipsychotics in a Naturalistic Setting (BPP)
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Purpose
Despite different pharmacological properties, the scientific evidence is inconclusive regarding which of the first-line second generation antipsychotics (SGAs) should be preferred for the individual patient suffering from psychosis. The limitations of the evidence base may be related to the highly selected samples, short duration, and rigid experimental designs of most randomized clinical trials of efficacy. Moreover a high proportion of the clinical trials are drug company sponsored which could introduce funding bias. The purpose of this non-commercially funded study is to investigate whether effectiveness differences exist among the first-line SGAs olanzapine, quetiapine, risperidone, and ziprasidone when the drugs are used in a representative clinical setting. Eligible patients are those admitted to hospital for acute psychosis and candidates for oral antipsychotic treatment. The investigators hypothesise that in the naturalistic setting of every-day clinical practice and in a diverse sample representative of most patients admitted for symptoms of acute psychosis, differential effectiveness among the SGAs could be disclosed when the patients are followed for up to 2 years. This could deliver valuable information regarding which SGA should be the starting antipsychotic drug in order to facilitate the most beneficial outcome.
| Condition | Intervention | Phase |
|---|---|---|
|
Psychotic Disorders |
Drug: Olanzapine Drug: Quetiapine Drug: Risperidone Drug: Ziprasidone |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
| Official Title: | Use, Effects and Side-effects of Second-generation Antipsychotics in a Naturalistic Setting. |
- Reduction of PANSS total score [ Time Frame: Admission, discharge/ 6 weeks if not discharged, 3, 6, 12, 24 months after admittance. ] [ Designated as safety issue: No ]
- Tolerability [ Time Frame: Discharge/ after 6 weeks if not discharged, 3, 6, 12, 24 months after discharge ] [ Designated as safety issue: Yes ]
- Time until initial drug discontinuation [ Time Frame: Up to 24 months follow-up ] [ Designated as safety issue: Yes ]
| Enrollment: | 226 |
| Study Start Date: | February 2003 |
| Study Completion Date: | January 2010 |
| Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Olanzapine |
Drug: Olanzapine
Olanzapine tablets 2.5mg - 20 mg per day once daily, or at the treating clinicians discretion
Other Name: Zyprexa
Drug: Quetiapine
Tablets, 25 mg-800 mg given twice daily, or at the treating clinicians discretion.
Other Name: Seroquel
Drug: Ziprasidone
Tablets, 20mg - 160 mg twice daily, or at the treating clinicians discretion
Other Name: Zeldox, Geodon
|
| Active Comparator: Quetiapine |
Drug: Olanzapine
Olanzapine tablets 2.5mg - 20 mg per day once daily, or at the treating clinicians discretion
Other Name: Zyprexa
Drug: Risperidone
Tablets, 1mg-6mg per day, once or twice daily, or at the treating clinicians discretion.
Other Name: Risperdal
Drug: Ziprasidone
Tablets, 20mg - 160 mg twice daily, or at the treating clinicians discretion
Other Name: Zeldox, Geodon
|
| Active Comparator: Risperidone |
Drug: Olanzapine
Olanzapine tablets 2.5mg - 20 mg per day once daily, or at the treating clinicians discretion
Other Name: Zyprexa
Drug: Ziprasidone
Tablets, 20mg - 160 mg twice daily, or at the treating clinicians discretion
Other Name: Zeldox, Geodon
|
| Active Comparator: Ziprasidone |
Drug: Olanzapine
Olanzapine tablets 2.5mg - 20 mg per day once daily, or at the treating clinicians discretion
Other Name: Zyprexa
Drug: Ziprasidone
Tablets, 20mg - 160 mg twice daily, or at the treating clinicians discretion
Other Name: Zeldox, Geodon
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Psychosis
- Must be able to use oral antipsychotic drugs
Exclusion Criteria:
- Mania
- Unable to cooperate with the assessments
- Unable to understand Norwegian language
- Candidates for electroconvulsive therapy
- Use of Clozapine at admittance
Contacts and Locations More Information
No publications provided by University of Bergen
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Hugo A. Jørgensen, University of Bergen |
| ClinicalTrials.gov Identifier: | NCT00932529 History of Changes |
| Other Study ID Numbers: | NSD-ID10591 |
| Study First Received: | July 2, 2009 |
| Last Updated: | May 24, 2010 |
| Health Authority: | Norway: Norwegian Social Science Data Services |
Keywords provided by University of Bergen:
|
Antipsychotic drugs Treatment effectiveness Randomized controlled trial |
Additional relevant MeSH terms:
|
Psychotic Disorders Mental Disorders Schizophrenia and Disorders with Psychotic Features Antipsychotic Agents Risperidone Quetiapine Olanzapine Ziprasidone Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses |
Psychotropic Drugs Serotonin Antagonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Dopamine Antagonists Dopamine Agents Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Antiemetics Autonomic Agents Peripheral Nervous System Agents Gastrointestinal Agents |
ClinicalTrials.gov processed this record on May 16, 2013